Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

EU Looks At New Ways To Boost Third-Country API Safety

Adequacy Of 'Written Confirmation' Policy Is In Doubt

Executive Summary

The EU is working on new measures to ensure the safety of active substances imported from third countries, suggesting that the current system of requiring written notifications is not fit for purpose. The move follows recent cases of nitrosamine contamination in medicines containing imported APIs.  

You may also be interested in...



Nitrosamine Episode Could Lead To Paradigm Shift In Quality

The detection of cancer-causing impurities in drugs with well-established safety profiles may force regulators across the globe to revise their approach for evaluating quality.

US, EU Hit Inspection Deal Milestone; Batch Test Waiver Kicks In

After 20 years in the making, the landmark GMP inspection MRA between the US and the EU is finally fully implemented. In addition, a batch test waiver has started to apply under the deal.

South Korea Passes EU's GMP Equivalence Assessment For APIs

The European Commission took four years to evaluate South Korea's regulatory framework for active pharmaceutical ingredients and to conclude that it is in line with EU standards.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS141422

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel